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A Phase III Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773 (10 and 25mg Once Daily) and Sitagliptin (100mg Once Daily) Given for Minimum 76 Weeks (Incl. 24 Weeks of Preceding Trial) as Monotherapy or With Different Back-ground Therapies in Patients With Type 2 Diabetes Mellitus Previously Completing Trial 1245.19, 1245.20 or 1245.23.

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Trial Profile

A Phase III Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773 (10 and 25mg Once Daily) and Sitagliptin (100mg Once Daily) Given for Minimum 76 Weeks (Incl. 24 Weeks of Preceding Trial) as Monotherapy or With Different Back-ground Therapies in Patients With Type 2 Diabetes Mellitus Previously Completing Trial 1245.19, 1245.20 or 1245.23.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Nov 2021

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At a glance

  • Drugs Empagliflozin (Primary) ; Metformin; Pioglitazone; Sitagliptin; Sulfonylureas
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms C-SCADE 6
  • Sponsors Boehringer Ingelheim Pharmaceuticals

Most Recent Events

  • 15 Sep 2017 Results of pooled safety analysis in >12,000 patients who were randomized to Empagliflozin (10 mg, 25 mg) or placebo in 15 Phase I-III trials plus 4 extension studies, presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes.
  • 16 Sep 2016 Results of a pooled analysis assessing risk of bone fracture presented at the 52nd Annual Meeting of the European Association for the Study of Diabetes
  • 16 Sep 2016 Results assessing safety data from 18 trials presented at the 52nd Annual Meeting of the European Association for the Study of Diabetes

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